12 Deaths Prompt Another Class I Recall For Medtronic’s HeartWare – The Firm’s Fourth In Recent Weeks

The medtech giant has racked up yet another high-risk class I recall designation from the US FDA, this time for HeartWare Ventricular Assist Device (HVAD) cables and controller ports. It’s also the second class I recall action for the HeartWare device in a little more than six weeks, and the company’s fourth overall.

Medtronic building.

Only a little more than six weeks separates two high-risk class I designations by the US Food and Drug Administration for recalls of Medtronic PLC’s HeartWare device.

The latest class I, announced by the agency on 15 April, comes because of “risk of wear and tear of...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Recalls

Deaths And Serious Injuries Linked To A Pair Of Heart Device Recalls

 

Two recent recalls from the US FDA involve three deaths linked to an issue with an Abiomed heart pump — as well as three serious injuries related to angiographic catheters from Cook Medical.

Serious Injuries Tied To Medtronic Bravo GERD Diagnosing System

 

The US FDA has issued an early alert to notify consumers about serious risks associated with a recall from Medtronic and its subsidiary Given Imaging. The alert concerns delivery capsules for diagnosing GERD.

A Year After Exiting The Ventilator Market, Medtronic Recalls Thousands Of Newport Devices

 

After two serious injuries and one death linked to some of its ventilators, Medtronic has recalled the devices and asked customers to stop using them and find alternative means. The action comes more than a year after the company left the market.

FDA Rebukes Four Companies, Including One Overseas, For Procedural Failures

 

The US FDA’s device center sent warning letters to three domestic device manufacturers and one German firm for failing to adhere to protocol on several issues.

More from Policy & Regulation

New Draft Guidance Clarifies FDA’s UDI Rules For Combination Products

 
• By 

The FDA has released draft guidance clarifying UDI rules for drug- and device-led combination products. The document specifies labeling requirements and makes recommendations to reduce confusion between UDIs and NDCs. Comments are being accepted until Sept. 24.

European Commission Asks For ‘Open Minds’ On Unified Drug/Device Research Pathway

 
• By 

As the EU tests the feasibility of a radical “all-in-one” procedure for combined drug and IVD studies, sponsors are being urged to approach this novel framework with flexibility and openness.

FDA Publishes Final Cybersecurity Guidance To Replace Final Cybersecurity Guidance

 

The US FDA has issued an updated final guidance document on cybersecurity considerations for medical device manufacturers that replaces a previous final guidance the agency issued in 2023.